Preparation, Medical Review and Submissions of Global Aggregate Reports ( PBRERs/PADER/ACO/PSUR)
Aggregate Reporting – PBRER, PADER, PSUR Writing
Aggregate reporting or Periodic Reporting deals with segregating all relevant safety data and compiling a pharmacovigilance document as per ICH guidelines, this report assesses benefit risk profile of a drug or biological product over a designated interval period (ranging from months to years).
By implementing and following periodic reporting, marketing authorization holder (MAH) is regulatory compliant and can review, update their respective product safety profile (Summary of Product Characteristics and Package Leaflet). All updated or new periodic safety reports are submitted by MAH to respective National competent authority (NCA).
Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Developmental Safety Update Reports (DSUR) and Periodic Adverse Drug Experience Report(PADER) are a valuable source of pharmacovigilance data for the competent authorities.
NCA place great importance on compliance with periodic reporting and expect MAH to strictly adhere to defined timelines which is specific based on time since product launch.
At iSafety, we have an expert medical writing team of highly experienced and trained health care professionals, who perform strategic planning, safety data write-ups, assessment and submission of safety reports.
We help companies/MAHs to meet their regulatory requirements within the defined time frames by evaluating case reports from summary tabulations, literature review and by monitoring regulatory updates from NCA.
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